On April 25, the Drug Controller General of India (DCGI) gave final approval to Biological E’s Corbevax COVID-19 vaccine for administration to children in the age group of 5-12 years, making it the first vaccine candidate in India to receive the regulator’s nod for inoculation in this age-group.
Biological E was the first vaccine manufacturing company in India to have received an advance payment of Rs 1,500 crore from the Centre for reserving 30 crore doses of Corbevax before it was granted emergency use authorisation (EUA) by the regulator in 2021, after the deadly second wave had hit India in May.
Today, over 3.39 crore doses of Corbevax vaccine has been administered to children in India in the age group of 12-14 years. Moneycontrol spoke to Lakshminarayana Neti, Chief Operating Officer (COO) of Biological E on new approvals, the vaccine’s efficacy against Omicron and other important issues related to Corbevax. Edited excerpts:
Corbevax has been permitted for administration in children of age group 5-12 years by DCGI. And there is huge demand for the vaccine. Please tell us about the vaccine production capacity?
Biological E has invested heavily to scale up its manufacturing capacity. Currently, we can manufacture more than 1 billion doses of Corbevax annually. We have committed to supply 300 million doses of Corbevax to the Government of India – these have been manufactured already. We have till now supplied close to 100 million doses to the Government of India for its immunisation program. We are committed to meeting the growing demand for Corbevax in India and globally.
Are you also looking at contract manufacturing of Corbevax or are you manufacturing only at your facilities?
Currently, we are not in discussions with any partner for contract manufacturing of Corbevax. Biological E has the manufacturing capacity to meet global demand.
Was NTAGI presented with data on Omicron for children? Was the primary safety endpoint for children reached?
Data on the Omicron variant in children was not part of our clinical trial endpoints. We have submitted all the data generated against multiple variants to regulatory agencies, including NTAGI. We are regularly making presentations to the regulatory bodies as more and more data gets generated.
At least one NTAGI member has gone on record and others off record to say the NTAGI, as a body, didn't approve the vaccine before the Govt announced the launch for older children - now it will be used in younger children. Do you feel this situation could have been avoided in whatever manner?
Our role as a vaccine developer is to share all relevant data with the concerned authorities. We have been sharing the data continuously with the regulatory agencies, including the NTAGI, at regular intervals.
WHO gives EUL listing only on the basis of efficacy data. Last time, BIO E had said that it was not ethical to conduct efficacy trials. Since there is no revision in the WHO guidelines, how do you think your application will move forward even if WHO does a site inspection? Is that not a hurdle for future approvals?
We firmly believe that giving placebo to subjects as part of efficacy trials during a pandemic setting despite approved vaccines being available and recommended would not be appropriate as it would make the placebo group to not take a vaccine during a pandemic.
Now we have convincing evidence that the protection against COVID-19 is correlated with titres of neutralising antibodies. Multiple countries have come out with guidelines on immunobridging trials, of which a major one is the UK MHRA which has already approved the Valneva COVID-19 vaccine based on immunobridging trials without any efficacy trials. We are also aware that WHO is considering the above subject across multiple consultative groups. Discussions with WHO are ongoing for EUL of Corbevax. We will update more in the near future.
We are seeing companies like Serum Institute of India and Bharat Biotech pausing the production of vaccines to avoid oversupplies. Do you think your vaccine can be competitive and you can supply even if the prices are reduced due to oversupply?WHO has clearly stated that no one is safe against COVID-19 until everyone is safe. There is still so much of inequality of vaccination coverage in lower and middle-income countries. We are regularly getting news reports of COVID-19 outbreaks in schools, resulting in closure of schools. As per UNICEF data, close to 15,000 children have died due to COVID-19, of which around 45 percent were below 12 years of age, and were not given COVID-19 vaccine. This itself calls for an expansion of the age group for vaccination amongst children, and hence, the need for vaccines is still huge. The price of the vaccine we supply to the government is known. We continue to be one of most affordable vaccines in India and globally.